ONE STEP MIDSTREAM HCG PREGNANCY TEST
FDA 510(k) clearance K974059 · decided 1998-04-09
Clearance details
- K-number
- K974059
- Device name
- ONE STEP MIDSTREAM HCG PREGNANCY TEST
- Applicant
- International Newtech Development, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-27
- Decision date
- 1998-04-09
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Delta, B.C., CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 recall (Z-0049-2024) | Universal Meditech Inc. | 2023-10-23 |
| PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS recall (Z-0055-2024) | Universal Meditech Inc. | 2023-10-23 |
| DiagnosUS Pregnancy Test Midstream REF 100-17 recall (Z-0066-2024) | Universal Meditech Inc. | 2023-10-23 |